NCT05066711

NuVasive® ACP System Study

A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® ACP System for the Treatment of Patients With Pathologic Conditions of the Cervical Spine

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).

Detailed description

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of the NuVasive ACP System in patients who undergo anterior cervical spine surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with pathologic conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo anterior cervical spine surgery using the NuVasive ACP System based on the surgeon's standard of care. At least 75 subjects will be enrolled and will be followed for 24 months after the surgery.

Conditions

• Cervical Spondylosis
• Cervical Radiculopathy
• Cervical Myelopathy
• Cervical Disc Disease
• Cervical Stenosis
• Cervical Disc Herniation
• Cervical Spine Disease

Timeline

• Start date: 2022-05-22
• Primary completion: 2026-09-30
• Completion: 2027-06-30
• First posted: 2021-10-04
• Last updated: 2025-12-22

Locations

3 sites across 1 country: United States